Prescrire international
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Anomalies in the international non-proprietary name (INN) nomenclature show that the international harmonisation of nonproprietary drug names has not been achieved. When pharmaceutical companies request a new INN, they try to obtain an INN that serves their interests, and then use it for promotional or anticompetitive purposes. Drug regulatory agencies are not fulfilling their duty to protect existing INNs, particularly with regard to biosimilars (copies of biotechnology-derived drugs), giving rise in particular to anomalous names. The independence of the World Health Organization INN programme must be safeguarded to ensure that the universal terminology it is responsible for developing is applied worldwide.
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Prescrire international · Oct 2014
Bedaquiline. More data needed on this dangerous antitubercular drug.
Active tuberculosis is a serious, sometimes fatal, bacterial infection. Multidrug-resistant strains are associated with higher mortality. Bedaquiline, a diarylquinoline antibiotic, has been authorised in the EU, in combination with other antibiotics, for patients with multidrug-resistant pulmonary tuberculosis. ⋯ The most frequently reported adverse effects were headache, nausea, arthralgia and pulmonary infections. In practice, bedaquiline reduced the number of contagious patients with multidrug-resistant pulmonary tuberculosis, but mortality was higher than in the placebo group. Its harm-benefit balance is unclear, especially in patients with extensively drug-resistant tuberculosis, for whom there are very few active antibiotics available.